Kornimate/medical-research-clean huggingface dataset:
the efficacy of fycompa (perampanel) in children with epilepsy

Conditions: Neurologic Disorder

Summary: fycompa (perampanel), a new anti-epileptic drug that uses a new mechanism-ampa receptor antagonist. its initial indication is for local or generalized epilepsy in children and adults over 12 years old, but its effectiveness in the treatment of epilepsy in children at present, more evidence is still needed. we will study the effectiveness of fycompa (perampanel) in the treatment of epilepsy in children under the age of 18. it is expected that the clinical use of fycompa (parampanel) in taiwan will be able to analyze and study the effectiveness of the clinical use of fycompa (parampanel) in the treatment of epilepsy in children, and compare it with foreign reports.


Eligibility criteria:
inclusion criteria: * patients under 18 years of age suffering from epilepsy * patients who are taking paraampanel exclusion criteria: * patients who are not in the above age groups and who are not using parampanel
apioc for presbyopia and apioc for presbyopia with astigmatism

Conditions: Presbyopia; Myopia; Hyperopia; Astigmatism

Summary: vision and comfort, both objective and subjective, will be assessed for single vision contact lens wearers for either the apioc™ for presbyopia or the apioc™ for presbyopia astigmatism contact lenses.


Eligibility criteria:
inclusion criteria: 1. the subject must provide written informed consent. 2. the subject must appear willing and able to adhere to the instructions set forth in this protocol. 3. at least 40 years of age and no more than 70 years of age. 4. ≤ 4.00 d of corneal astigmatism. 5. ≤ 2.50 d of refractive astigmatism. 6. refractive error range +4.00 ds to -6.00 ds 7. require a reading addition (bifocal) of at least 0.75 d 8. flat and steep keratometry readings within 40 to 48 d. 9. clear, healthy corneas with no irregular astigmatism. 10. normal, healthy conjunctiva in both eyes. 11. free of active ocular disease. refractive error and presbyopia are permitted. 12. be a current or former (within the last 3 years) contact lens wearer. 13. best-corrected near and distance visual acuity better than or equal to 20/25. exclusion criteria: 1. irregular corneal astigmatism. 2. corneal scarring unless off line-of-site and well healed. 3. pinguecula, pterygium, or other conjunctival thickness abnormalities that would interfere with soft contact lens wear. 4. recent use of any ocular pharmaceutical treatments, including daily artificial tears, in the two weeks prior to the examination. occasional artificial tear use is permitted. 5. systemic disease that would interfere with contact lens wear. 6. currently pregnant or lactating (by self-report). 7. history of strabismus or eye movement disorder, including exophoria at near that is 4 d or greater than at far, and a receded near point of convergence break that is 6 cm or greater. 8. active allergies that may inhibit contact lens wear. 9. upper eyelid margin at or above the superior limbus. 10. history of ocular or lid surgery. 11. immediate family members or significant others of doctors or staff at the clinical site.
prevalence and severity of colour vision deficiency among turkish children

Conditions: CAD Test; Children's Vision; Colour Assessment; Colour Vision; Turkey

Summary: to evaluate the usability of the colour assessment and diagnosis (cad) test in children. to determine the prevalence of colour vision deficiency (cvd) among turkish children, to identify the class of deficiency and to quanify severity of loss.


Eligibility criteria:
inclusion criteria: children with aged 6-16 years, who attended the ophthalmology department at the istanbul medipol university - exclusion criteria:children with known or current evidence of ocular pathology (other than refractive errors), with history of long term use of medication, previous ocular surgery and those with chronic systemic diseases were excluded from the study -
testosterone treatment for hypogonadal men

Conditions: Hypogonadism

Summary: demonstrate efficacy and safety of testosterone gel 1.62% for the treatment of hypogonadal men


Eligibility criteria:
inclusion criteria: * low t males 18 - 80 years of age exclusion criteria: * normal t levels * elevated prostatic specific antigen (psa)

Keywords: hypogonadism testosterone deficiency
body temperature changes and early postoperatıve pressure sore

Conditions: Pressure Sore; Orthopedic Disorder; Hypothermia; Nursing Caries

Summary: this study aims to determine effect of body temperature changes during total knee arthroplasty surgery on early postoperative pressure sore formation.

background: intraoperative hypothermia for a prolonged period increases the risk of hospital-acquired pressure sores. purpose: this study aims to determine effect of body temperature changes during total knee arthroplasty surgery on early postoperative pressure sore formation. methods: this experimental study was performed with experimental-control group (n=122) patients. data were collected with "personal information form", "body and ambient temperature record form", "braden risk assessment scale". experimental group participants were covered with a wool blanket, and control group was given standard care.

Eligibility criteria:
inclusion criteria: * aged 20-85 years * hospitalized for at least four days and accepted to participate were included in the study. exclusion criteria: * under the age of 20 - over 85, * pregnant and having comorbid diseases, * spinal cord injuries, * skin problems in areas where there is a risk of pressure loss, * undergoing hemodialysis, * having creatinine and serum albumin levels higher than 3 mg/dl, * having immobility, incontinence, anemic, having malignant tumor(s), * bmi \ 40, * hemoglobin level below 10 g/dl, * infection, * american society of anesthesiology (asa) score of 3 or more, * experiencing friction, tearing and shearing, * undergoing more than one surgical intervention, * having conditions requiring the use of non-normal anesthetic agents and sedation, * using vasoconstrictive drugs, * using positioning devices, * undergoing prolonged surgical intervention, * having arterial pressure lower than 32 mmhg, * having diabetes mellitus requiring insulin therapy.
a clinical study of 6mw3211 monotherapy or combination therapy for aml or mds

Conditions: Acute Myeloid Leukemia; Myelodysplastic Syndrome

Summary: this study is aimed to evaluate the efficacy, safety, immunogenicity and pharmkinetics, pharmacodynamics of 6mw3211 as monotherapy and in combination with aza or aza plus ven in patients with aml/mds.

this study is a phase i/ii study to evaluate the pharmacokinetics, pharmacodynamics, efficacy and safety of 6mw3211 monotherapy or combined with aza or aza plus ven in patients with aml and mds. there will be 2 parts of this study. the phase ib is about monotherapy of 6mw3211 and phase ii is designed to evaluate the safety and efficacy of 6mw3211 combined with aza or aza plus ven in patients with relapse/refractory and newly diagnosed aml and mds.

Eligibility criteria:
inclusion criteria: * voluntarily participate in the study and sign the informed consent; * 18≤age≤75，men or women； * aml patients (except acute promyelocytic leukemia) : subjects who meet the diagnostic criteria for relapsed/refractory aml according to the diagnostic criteria of 2021 chinese guidelines for the diagnosis and treatment of relapsed and refractory aml ； mds patients: mds patients were diagnosed as having moderate risk of recurrence/refractory (ipss-r score \>3.5) according to who diagnostic criteria in 2016 * ecog:0-2; * survival expectation of at least 3 months; * adequate organs and hematopoietic functions; only applicable for phase ii : * newly diagnosed aml with intolerance to standard induction chemotherapy who should meet one of following criterias: age ≥75 years; ecog 2-3; chronic heart failure requiring treatment or ef≤50% or chronic stable angina pectoris; dlco≤65% or fev1≤65%;30ml/min≤crcl\<45ml/min；1.5 x uln\<total bilirubin≤3.0 x uln * newly diagnosed intermediate- and high-risk (international prognostic scoring system ipss-r) mds exclusion criteria: * myeloid proliferative diseases (mpn), including primary myelofibrosis (pmf), polycythemia vera (pv), chronic myelogenous leukemia (cml), and primary thrombocytopenia (et); or have myelodysplastic myeloid proliferative tumors (mds-mpn), including chronic monocytic leukemia (cmml), atypical chronic myelogenous leukemia (acml), juvenile granulomatous single-cell leukemia (jmml), and acute promyelocytic leukemia (m3); * recurrence after allogeneic hematopoietic stem cell transplantation, or autologous hematopoietic stem cell transplantation within 1 year; * known infiltration of central nervous system leukemia； * active or uncontrolled autoimmune diseases； * has a history of other malignancies； * has known inherited or acquired hemorrhagic disorders； * pregnant or lactating women；
trial of onset of epidural pain relief with low dose bupivacaine and different doses of fentanyl in laboring women

Conditions: Anesthetic, Sedative or Analgesic Complications in Labor or Delivery

Summary: epidural analgesia is the most effective form of labor pain relief. low doses of local anesthetic (freezing solutions) in combination with opioids (narcotics) are commonly used as epidural solutions to provide pain relief. low dose local anesthetic solutions with opioids for labor have been shown to decrease motor block (leg weakness or temporary paralysis), without affecting labor pain relief. however, onset of pain relief can be delayed with these low dose solutions. the standard epidural solution used at victoria hospital is a low dose of local anesthetic called bupivacaine mixed with fentanyl, an opioid, for labor epidural pain relief. there is some evidence that the addition of more fentanyl to the epidural bolus dose of bupivacaine at the start of labor epidural analgesia can speed onset of pain relief. both medications are safe for you and your baby. this study will investigate whether the addition of different doses of fentanyl (20 mcg, 50 mcg and 100 mcg) to the epidural bolus dose speeds onset of pain relief. the study hypothesis is that the onset of epidural labor analgesia will be shortest with the larger fentanyl epidural bolus.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) physical status 1 or 2 * pregnant women in early labor (cervical dilation \<5cm) * singleton fetuses * gestational age more than 36 weeks * normal fetal heart rate tracing exclusion criteria: * severe pre-ecclampsia * antepartum hemorrhage * asa \>3 * chronic pain * substance abuse * language barrier between patient and investigator * contraindications to epidural analgesia * allergies to local anesthetics or fentanyl * morbid obesity * previous administration of opioid analgesia

Keywords: labor epidural analgesia fentanyl bupivacaine onset
effect of hepatic impairment on the pharmacokinetics, safety and tolerability of bay1002670 (vilaprisan)

Conditions: Leiomyoma

Summary: evaluate the potential effect of hepatic impairment on the pharmacokinetics, safety and tolerability of bay1002670 (vilaprisan)


Eligibility criteria:
inclusion criteria: for all subjects: * the informed consent must be signed before any study specific tests or procedures are done * white/caucasian men and women aged between 18 to 79 years (inclusive ) * body mass index (bmi): 18 to 34 kg/m2 (both inclusive) * ability to understand and follow study-related instructions * women and men of reproductive potential must agree to use adequate contraception when sexually active. this applies for the time period between signing of the informed consent form and three months after administration of study drug. subjects must agree to use two non-hormonal methods for contraception simultaneously (e.g. condom or diaphragm, plus spermicide) throughout the study when sexually active. this is not required if safe contraception is achieved by a permanent method, such as hysterectomy, bilateral fallopian tube ligation or vasectomy. for subjects with hepatic impairment: * subjects with documented liver cirrhosis confirmed by histopathology, laparoscopy, fibroscan, or ultrasound * subjects with hepatic impairment (child-pugh a or b) * subjects with stable liver disease, i.e. same child-pugh class in the last 2 months exclusion criteria: * any relevant disease within 4 weeks prior to study drug administration requiring medical treatment * known severe allergies, non-allergic drug reactions, or multiple drug allergies * use containing sex hormones within 4 weeks to six months before first study drug administration * use of cyp3a4 and p-glycoprotein inhibitors or inducers * use of drugs which may affect absorption * major change of medication \<2 weeks prior study drug administration * deviations from normal range in physical examination, gynecological examination, clinical chemistry, hematology, or urinalysis considered to be relevant by the investigator * any criteria which, in the opinion of the investigator, make study participation unadvisable for scientific, compliance, safety, or medical reasons

Keywords: pharmacokinetics
an evaluation of the implementation of the care and monitoring at home program- a new paradigm for acute care management of cancer patients

Conditions: Cancer

Summary: to understand the experience of patients receiving care in the care and monitoring at home program at md anderson. researchers intend to use this information to study and possibly improve the hospital care at home program.

objectives primary objectives the objective of this observational study is to assess the feasibility of providing hospital substitution hospital level care in the home for patients with cancer through the camh program. our primary gauge of feasibility will be a care escalation rate of \ 3 on each of three post-discharge survey implementation measures - the feasibility of implementation measure, acceptability of implementation measure, and intervention appropriateness measure. secondary objectives secondary objectives will include patient experience and perception about camh, length of stay, rate of clinical adverse events during camh (falls, pressure ulcers, medication errors) and 30-days after discharge, 7-day readmission, 30-day readmission, and 30-day emergency department visit rate. (note, the aforementioned adverse events could occur as a result of participation in camh. however, minimal adverse events are expected a result of participation in this observational study (see adverse events below)). a patient will be considered to have an er visit or hospital readmission if these events are documented in the medical record or the patient reports the event on the survey.

Eligibility criteria:
inclusion criteria: * participants will be eligible for enrollment in this study if they have accepted enrollment in camh. no patients will be excluded if they are enrolled in camh. * cognitively impaired adults will be able to participate in the study if an adults proxy provides informed consent and completes survey materials on their behalf. exclusion criteria: - children and pregnant women will not be enrolled in the camh program, and therefore not eligible for this study.
identifying progression of retinal disease in eyes with npdr in diabetes type 2 using non-invasive procedures

Conditions: Type 2 Diabetes; Non Proliferative Diabetic Retinopathy

Summary: the purpose of this study is to identify eyes that show worsening and disease progression (progressor phenotypes).

to identify "progressors" in retinal vascular disease and central retinal edema in type 2 diabetic patients with early npdr, based on retinal disease progression from baseline to the 12-month visit, assessed by the following biomarkers: * microaneurysms turnover (ma formation rate over or equal to 2, i.e. number of new ma from baseline to the 12-month visit) computed from color fundus photographs using the retmarkerdr software; and * retinal thickness increase in eyes with retinal thickening (increase in retinal thickness above normal range) in the central subfield, the inner ring and/or the outer ring constantly present, present or absent (as measured by oct and considering the macula thickness normative data.

Eligibility criteria:
inclusion criteria: 1. diabetes type 2 according to 1985 who criteria 2. age between 35 and 75 years 3. mild non-proliferative diabetic retinopathy (levels 20 or 35, based on the etdrs criteria) - 7 fields color fundus photography 4. presence of at least 1 microaneurysm in the central 3000 micr. in diameter area (corresponding to 2 da) - field 2 5. best corrected visual acuity \>= 75 letters (\>= 20 /32) 6. refraction with a spherical equivalent less than 5 dp 7. informed consent exclusion criteria: 1. cataract or other eye disease that may interfere with fundus examinations 2. glaucoma 3. any eye surgery within a period of 6-months 4. other retinal vascular disease 5. previous laser therapy 6. dilatation of the pupil \< 5 mm
comparison of the right and left internal jugular vein using ultrasound

Conditions: Comparison of the Right and Left Internal Jugular Vein Using Ultrasound

Summary: the purpose of this study is to determine whether there is a difference between the diameter, and the cross-sectional area of the right internal in left internal jugular vein in preoperative, mechanically ventilated patients. secondary the relationship between the internal jugular vein to the common carotid artery will be examined.

placement of a central venous catheter (cvc) for surgery is used for hemodynamic monitoring and venous access. most often the right internal jugular vein (rijv) is used. the rijv is preferred over the left-sided internal jugular vein (lijv) because cannulation of the lijv is more difficult and associated with a higher complication rate(1). a possible explanation for the higher complication rate can be explained by the difference in diameter between the rijv and the lijv. it has been demonstrated that large vessels are easier to catheterize than small ones. data suggest that the internal jugular veins are most often asymmetric but data are limited. until now, there is one small prospective study in which 80 icu patients where examined (30 patients were mechanically ventilated) which showed an asymmetry in 62,5% and a dominant rijv in 68% and a smaller study performed by lobato and colleagues in which 50 healthy patients were examined. they measured the cross-sectional areas of the internal jugular veins. they showed that in 80% the rijv was greater than the lijv. two ct studies has been done so far. in 2009 tartière and colleagues carried out an observational study in 190 patients. all patients were in the supine position, neutral head position an spontaneous breathing. during the ct patients were asked to hold there breath. the study showed that the diameter and cross-sectional area of the rijv were significantly greater than those of the lijv. a smaller retrospective ct-study (88 patients) performed by lim et al in 2006 showed a larger rijv in 79,5% compared to the lijv. until now, there are no data known about the difference between the rijv and lijv in preoperative mechanical ventilated patients when ultrasound is used.

Eligibility criteria:
inclusion criteria: * all patients who will need a central venous access preoperative are included (e.g. for medication, nutrition, antibiotics)and are mechanically ventilated exclusion criteria: * \< 18 years of age * neck or head surgery in the past * radiation therapy of the neck * known thyroid pathology * skeletal deformities.

Keywords: ultrasound left and right jugular vein comparison
safety and efficacy of andecaliximab in participants with moderately to severely active crohn's disease

Conditions: Crohn's Disease

Summary: this study will primarily evaluate the safety and efficacy of andecaliximab in adults with active crohn's disease. the study will consist of a double-blind phase of 8 weeks followed by an open-label extension. participants who complete the double-blind phase will be eligible to enroll in the optional open-label extension for an additional 44 weeks. participants who complete week 52 assessments will be eligible to enter the extended treatment phase to continue treatment with andecaliximab for an additional 156 weeks.


Eligibility criteria:
key inclusion criteria: * ability to provide a written informed consent * females of childbearing potential must have a negative pregnancy test at screening and baseline * documented diagnosis of crohn's disease with a minimum disease duration of 6 months with involvement of the ileum and/or colon at a minimum * moderately to severely active crohn's disease as defined by a crohn's disease activity index (cdai) total score between 220-450 (inclusive) and with evidence of active disease as measured by ileocolonoscopy * within the previous 5 years, demonstrated an inadequate clinical response or intolerance of at least one of the following agents: * corticosteroids * immunomodulators * tumor necrosis factor-alpha (tnfα) antagonists * vedolizumab * may be receiving the following drugs: * oral 5-aminosalicylate (5-asa) * oral corticosteroid therapy * antidiarrheals for chronic diarrhea * azathioprine or 6-mercaptopurine (6-mp) or methotrexate * antibiotics for the treatment of crohn's disease * able to comply with the dosing instructions for study drug and able to comply with the study visits and requirements key exclusion criteria: * evidence of abscess at screening * extensive colonic resection (subtotal or total colectomy) or history of \> 2 small bowel resections * ileostomy, colostomy, or symptomatic stenosis of the intestine * current use of oral corticosteroids at a dose equivalent to \> 30 mg/day of prednisone * ulcerative colitis or indeterminate colitis * short bowel syndrome * stool sample positive for clostridium difficile (c. difficile) toxin, e. coli, salmonella, shigella, campylobacter or yersinia * treatment with any monoclonal antibody within 4 weeks of screening * history or evidence of colonic mucosal dysplasia * hiv, hepatitis b, hepatitis c, or tuberculosis (tb) infection * participated in a clinical study with an investigational drug or biologic within the last 30 days * any chronic medical condition (including, but not limited to, cardiac or pulmonary disease) that, in the opinion of the investigator, would make the individual unsuitable for the study or would prevent compliance with the study protocol note: other protocol defined inclusion/ exclusion criteria may apply.
exercise prehabilitation in patients with head and neck squamous-cell carcinoma: the fit4treat trial

Conditions: Head and Neck Neoplasms

Summary: the main purpose of this randomized-controlled trial is to evaluate the effects of prehabilitation based on exercise training (et) on functional capacity in hnc patients treated with chemoradiotherapy (crt). forty-six participants will be randomized (1:1 ratio) into prehabilitation and usual care groups. the length of intervention will be at least 2 weeks. data will be collected at diagnosis, immediately before anti-cancer treatment start and 4 weeks following crt. primary outcome is functional capacity as assessed by the six-minute walk test. additional measures include muscle strength, endothelial function, arterial stiffness, inflammatory biomarkers, body composition, quality of life, treatment tolerance, compliance to treatment, progression-free survival, and overall survival.


Eligibility criteria:
inclusion criteria: * age ≥18 years old; * histologically confirmed hnscc located on the oral cavity, larynx, oropharynx, hypopharynx, nasopharynx or in lymph nodes from an unknown primary tumor (stage i-iv); * proposed for concomitant chemoradiotherapy with curative intent; * date of treatment beginning ≥2 weeks from baseline assessment; * ecog-performance status 0-1. exclusion criteria: * completion of previous anticancer treatment within less than a year; * uncontrolled hypertension, cardiac or pulmonary disease; * contraindications to exercise training; * inability to provide informed consent; * expected inability to fulfil the proposed schedule.

Keywords: prehabilitation exercise head and neck cancer